Ampoule comprising an ampoule holder

ABSTRACT

An ampoule holder for receiving an ampoule that has a closure element with a radial projection, the ampoule holder including an ampoule seat and a securing member operably coupled to the ampoule seat, wherein the radial projection of the closure element can be arranged between the ampoule seat and securing member.

CROSS-REFERENCED RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationNo. PCT/EP2009/056333 filed May 25, 2009, which claims priority toGerman Patent Application No. 10 2008 025 011.2 filed May 24, 2008, theentire contents of each of which are incorporated herein by reference.

BACKGROUND

The present invention relates to devices for injecting, delivering,administering, infusing or dispensing a substance, and to methods ofmaking and using such devices. Such devices often involve container,vial, ampoule, carpoule or reservoir for containing the substance, andmore particularly, the present invention relates to an ampoule holderfor accommodating an ampoule. The teem ampoule is intended refer to anysuitable container-like item, e.g. a vial, etc., from the field ofmedical technology, in which is contained a product, e.g. a therapeuticor medicinal substance, to be administered using one of theafore-mentioned devices. The term ampoule can refer to both aone-chamber ampoule and multi-chamber ampoules, e.g. a two-chamberampoule.

Ampoules are known from the prior art which comprise a cylindrical wallwhich surrounds a plunger or piston which abuts the inner side of thewall, forming a seal. The plunger can be shifted relative to the wall inthe direction of an outlet. The product is situated between the plungerand the outlet. The product container is sealed at the outlet with aseal or septum. The seal can be penetrated by a sharp object, e.g. aneedle, cannula, etc. The known ampoules comprise an ampoule neck, atwhich the ampoule tapers, between the cylindrical casing wall and theseal. The known seals have a smaller outer diameter than the cylindricalcasing wall. The smaller diameter of the seal serves to enable theampoule to be inserted into an ampoule holder from the proximal (rear)opening of the ampoule holder and to be pressed into a fixed fit withthe ampoule holder via the tapering part of the ampoule neck. The smalldiameter of the seal enables the septum to be penetrated with arelatively thin needle. Thin needles have the advantage that they do notcause the patient as much pain during injecting, but the disadvantagethat the delivering force which has to be applied to the plunger todeliver the product is relatively large, since the product has to bepressed through a thin channel of the needle. This effect is moresignificant the higher the viscosity of the product contained in theampoule.

SUMMARY

The present invention relates to and/or involves drugs, therapeuticsubstances, medicinal substances and the like, e.g. in liquid or fluidform, for being administered to a patient. The fluid drug can be ahomogeneous or heterogeneous fluid. The fluid can be a dispersion, e.g.a suspension or an emulsion. A suspension describes systems consistingof a fluid and particles of solid, such as particles of powder,suspended in it which are practically insoluble. An emulsion isunderstood to mean a finely distributed mixture of two different fluidswhich cannot normally be mixed. The fluid or liquid may have a low or ahigh-viscosity. The present invention also relates to and/or involvessuitable containers.

In some embodiments, a product container in accordance with the presentinvention can be an ampoule, which also encompasses the term carpoule.An ampoule is described in the following as a representation of suitableproduct containers.

In some embodiments, the ampoule comprises a casing which isrotationally symmetrical. The casing, or at least a part of it, iscylindrical or tubular. The distal (front, forward or injection) end ofthe ampoule comprises a seal which can be penetrated by a needle orsimilar elongated, pointed object. The ampoule, e.g. its cylindricalcasing, is open at the proximal (rear) end, such that a drive member,such as a plunger rod, can act on a plunger or piston which is mountedby or carried in the casing.

In some embodiments, one or more plungers can be accommodated in theampoule. The ampoule can thus be a one-chamber ampoule comprising asingle plunger or a multiple-chamber ampoule comprising two plungersarranged in succession in the longitudinal direction.

In a one-chamber ampoule, the fluid product to be administered isbetween the plunger and the seal. The product can be delivered throughthe seal by shifting the plunger in the direction of the seal. Theplunger, which abuts the inner wall of the casing, forming a seal, canbe shifted along the cylindrical part of the casing.

In a two-chamber ampoule, the drug to be delivered is first merged ormixed from two constituents, before an injection. The two-chamberampoule generally comprises a first chamber for a first constituent anda second chamber for a second constituent, wherein in the initial state,the two constituents are separated from each other, e.g. by a membraneor a plunger. Storing the constituents separately can increase thestorage or shelf life of the drug, since the mixed drug only has arelatively short shelf life. The constituents are combined when beingmixed. Mixing can be performed by inserting the two-chamber ampoule intoa device which is adapted for such ampoules. The first chamber for thefirst product constituent is arranged between the seal and the firstplunger. The second product constituent is arranged between the firstplunger and the second plunger. The second plunger is situatedproximally with respect to the first plunger. Both plungers abut theinner circumference of the casing, forming a seal, and can be shiftedrelative to the casing in the longitudinal direction.

In some embodiments, one product constituent, e.g. a solid productconstituent such as a particulate or powdery product constituent, can besituated in the first chamber. Storing the product constituent in thefirst chamber in a dry state can increase the shelf life of the productconstituent. A fluid product is situated in the second chamber.

In some embodiments, the two-chamber ampoule can comprise a so-calledbypass which comprises a recess, which protrudes or extends radiallyoutwardly in the cylindrical part of the casing. The recess is formed tobe elongated, i.e. longer than it is wide, and exhibits a length whichis larger than the length of the first plunger.

A shifting movement of the second plunger can be transferred onto thefirst plunger via the product constituent situated in the secondchamber. In a shifted position of the first plunger, in which the bypassextends beyond the first plunger both distally and proximally, thesecond plunger can be movable relative to the first plunger. This canreduce the volume between the first plunger and the second plunger, thusenabling the product constituent contained in the second chamber to flowvia the bypass into the distal chamber, i.e. the first chamber, or thuspressing the product constituent contained in the second chamber via thebypass into the distal chamber, i.e. the first chamber. The productconstituents thus combined can be mixed. To administer the productmixture, the distal facing side of the second plunger can abut againstthe proximal facing side of the first plunger. The first plunger and thesecond plunger can then be jointly moved in the distal direction todeliver the product mixture.

In some embodiments, the seal of the ampoule is formed at its distal(front, forward) end. The seal can comprise a penetrable material orstructure which plastically expands when penetrated, in accordance withthe injected object, e.g. a needle or a continuation of a needle unit.After the body which has penetrated the seal has been removed, the sealcan remain open in accordance with the plastic deformation. The sealcomprises a material which can be elastically deformed when penetrated,such that it conforms around the diameter of the penetrating object andabuts it in a fluid seal. When the penetrating object is removed fromthe seal, the latter can seal itself again in a fluid seal due to itselasticity. The penetration of dirt into the product container and theescape of product from the product container can thus be avoided. If abody is again injected through the seal, the latter can again expand dueto its elasticity and again conform against the circumference of thepiercing object in a fluid seal. The ampoule can thus also be providedfor dispensing product in a number of doses, for each of which a newneedle unit is used. A used needle unit can be exchanged for a new onebetween the injections.

The elastic part of the seal can be referred to as a septum which can beformed from a synthetic material, natural rubber or another suitablematerial.

In some embodiments, the ampoule exhibits an outer diameter on itscylindrical casing. The outer diameter of the cylindrical part of theampoule can be approximately as large as an inner diameter of an ampoulereceptacle, such that the ampoule receptacle can receive, mount or guidethe cylindrical part of the casing.

In accordance with the present invention, in some embodiments, the sealprotrudes or extends radially beyond the diameter, i.e. the outercircumference area, of the cylindrical part of the ampoule. The diameterwhich results in the case of a rotationally symmetrical seal can belarger than the diameter of the cylindrical part of the casing. In someembodiments, the outer diameter of the seal is the maximum diameter ofthe ampoule as a whole.

In some preferred embodiments, the seal can comprise at least the septumwhich exhibits a larger diameter than the cylindrical casing portionand/or protrudes or extends radially beyond the cylindrical casingportion. The seal can also comprise a projection which is formed at thedistal end of the casing of the ampoule and protrudes radially beyondthe outer circumference of the cylindrical casing part. The projectioncan be annularly circumferential, such that it can exhibit a largerouter diameter than the cylindrical casing part. The annularlycircumferential projection can be referred to as a bulge. The annularprojection can be connected, e.g. integrally, to the cylindrical casingportion, directly or indirectly via a portion which exhibits a reducedouter diameter and can be referred to as an ampoule neck. The casing,which is formed from the cylindrical casing part, the annularlycircumferential projection and optionally the ampoule neck, can beformed from glass or another suitable material, e.g. a transparent,synthetic material.

In some embodiments, the ampoule neck can exhibit both an outer diameterwhich is reduced relative to the outer diameter of the seal and theouter diameter of the cylindrical part and/or an inner diameter which isreduced relative to the inner diameter of the cylindrical casing part.The reduced inner diameter can mean that the plunger can only be shiftedas far as the end of the cylindrical part. The length and position ofthe ampoule holder can be adapted such that the opening and/or the tipof a piercing object which is inserted through the seal can come to restaxially in the region of the ampoule neck and/or the seal. It is thuspossible to avoid the plunger abutting against the piercing object orbeing pressed too firmly against the piercing object when the piercingobject is inserted through the septum into the product container.

In some embodiments, the seal, and/or also the bulge and the septum, cancomprise an approximately cylindrical circumferential area in the regionof the seal. The seal can comprise an element which connects the septumand the casing, e.g. the annularly circumferential projection orextension, and/or holds them in a connection. This part can surround theseptum and the bulge over their outer circumference. The element canalso clasp the septum distally and clasp the bulge proximally, toaxially secure the septum to the bulge in a fluid seal. The regionexhibiting a reduced diameter of the ampoule neck can be advantageous,since the element can clasp the bulge further radially inwardly thanwithout the region exhibiting a reduced diameter. The element can be aremolded (or deformed or deformable) element which during manufacture iscorrespondingly remolded around the bulge and the septum placed onto thebulge. On the distal facing area of the seal, the element can comprise abreach which is circular and allows direct access to the septum.

In some embodiments, the septum can comprise a disc-shaped region whichexhibits approximately the diameter of the bulge. The septum can alsocomprise a hollow-cylindrical region which projects or extendsproximally from the disc-shaped region. The hollow-cylindrical diametercan exhibit an outer diameter which approximately corresponds to theinner diameter of the casing in the axial region of the bulge. Thecylindrical region of the septum can thus serve as a centering aid. Theinner space or cavity formed by the hollow-cylindrical part of theseptum can serve to accommodate one or more openings of the piercingobject, e.g. needle, of an attached needle unit.

In some embodiments, the bypass of the ampoule can project or extendfrom the outer circumference of the cylindrical part of the ampoule.

In some embodiments, the ampoule can be arranged together with anampoule holder on or in an injection device, wherein the ampoule holdercomprises an ampoule receptacle and a fastening member, wherein theradial projection of the seal is arranged, e.g. enclosed, between theampoule holder and the fastening member. This enables the ampoule holderto be axially fixed, e.g. for a movement in the distal direction andproximal direction. An axial clearance, or gap or shifting, of theproduct container such as may arise can be reduced or even eliminated,as described further below.

In some embodiments, the ampoule receptacle can be sleeve-shaped, withan inner diameter which approximately corresponds to the outer diameterof the cylindrical part of the ampoule, such that the ampoule islaterally guided by the ampoule receptacle. The ampoule receptacle cancomprise a thread, e.g. an outer thread, which can engage with acorresponding counter thread of an injection device, such that theampoule receptacle can be axially shifted into the casing, e.g. by acombined rotational and axial movement. Instead of the thread, an axialguide or other components can also be provided, as long as they allowthe axial movement of the ampoule receptacle into the injection device.

In some embodiments, the fastener or fastening member can be fastened orfastenable to the ampoule receptacle. The fastening member can be formedintegrally with the ampoule receptacle, or are joined separate partswhich together form the ampoule holder.

In some embodiments, the fastening member can be or comprise aprojection which acts on a facing side of the seal of the ampoule, e.g.the distal (forward) facing side. The projection can be a resilient arm,snapper, cam or the like, wherein the projection can extend radiallyinwardly from without.

In some preferred embodiments, the ampoule can abut the ampoulereceptacle, e.g. the facing side of the ampoule receptacle or aprojection on the ampoule receptacle which is directed radially inwardlyfrom an inner circumference, via the proximal side of the seal. In theregion where the facing side of the seal is intended to enter into axialabutment, the ampoule receptacle comprises a region exhibiting a reducedinner diameter which is smaller than the outer diameter of the seal andlarger than the cylindrical part of the casing. In some embodiments, afacing area of the ampoule receptacle, e.g. the distal end, can providethe abutment for the seal, e.g. its proximal end.

In some embodiments, the ampoule is inserted or is able to be insertedwith its proximal end first, i.e. with its cylindrical casing part tothe fore, into the ampoule receptacle through the proximal facing sideof the ampoule receptacle. When the ampoule is inserted, the fasteningmember can be deflected and can snap back in the completely insertedposition to axially fix the ampoule in at least one direction.

In one embodiment, the present invention comprises an ampoule holder forreceiving an ampoule that has a closure element with a radialprojection, the holder comprising an ampoule seat and a securing memberoperably coupled to the ampoule seat, wherein the radial projection ofthe closure element can be arranged between the ampoule seat andsecuring member.

In some preferred embodiments, the fastening member can be connected tothe ampoule receptacle in a positive fit such that it is rotationallyand axially fixed relative to the ampoule receptacle. The ampoulereceptacle and the fastening member can comprise mutually engagingelements which mutually engage or latch into or onto each other, e.g.when the fastening member is placed completely onto the ampoulereceptacle.

In some embodiments, e.g., in case a two-chamber ampoule is insertedinto the ampoule receptacle instead of a one-chamber ampoule, theampoule receptacle can comprise a cavity, which extends from thedirection of the facing side along the ampoule receptacle, for thebypass of the two-chamber ampoule. A number of such cavities can beprovided, distributed over the circumference, such that the ampoule canbe inserted into the ampoule receptacle in almost any angular position.The cavity for the bypass can comprise rotational abutments which act inthe circumferential direction and prevent a rotation of the ampoulerelative to the ampoule receptacle when the ampoule is inserted.

In some embodiments, at least one of the ampoule receptacle and thefastening member can comprise at least one projection, e.g. a cam, whichis directed toward the seal. The at least one projection or cam canextend in the longitudinal direction of the ampoule or ampoule holder,e.g. in the distal direction or proximal direction. The seal, e.g. itsfacing side, abuts the at least one cam. The point-focussed abutment forthe seal which is caused by the cam can reduce a clearance in the axialenclosure of the seal. The at least one projection can be arranged onthe ampoule receptacle and/or fastening member rigidly or such that itis sprung, or biased or urged, in the axial direction.

In some embodiments, the at least one projection, e.g. a cam, can bearranged on the ampoule receptacle, namely where the completely insertedproduct container enters into axial abutment, e.g. on the facing area ofthe ampoule receptacle. The at least one projection can alternatively oradditionally be formed on a projection of the fastening member which isdirected radially inwardly, e.g. where the fastening member clasps thefacing side of the seal.

In some embodiments, the ampoule holder, e.g. the ampoule receptacleand/or the fastening member, can comprise features or a structure whichenable a needle unit to be fastened to the ampoule holder. The needleunit can be plugged on via a conical area or screwed on via a thread.When a needle unit is arranged on the ampoule, it can for be fastened tothe ampoule holder via a fastening portion. When a needle unit iscompletely fastened, a piercing object, e.g. a sharp continuation or aneedle, can penetrate the septum and establish a fluid connectionbetween a distal needle tip of the needle unit and the productcontainer. The needle unit is fixedly screwed to the fastening membervia an inner thread with which an outer thread of the needle unit canengage.

In some embodiments, the ampoule receptacle can comprise features orstructure, e.g. a thread, using which it can be fastened to an injectiondevice and, when fastened, moved into the injection device by an axialmovement combined with a rotational movement. The ampoule receptacle cancomprise one or more latching elements which generate an acoustic and/ortactile signal by latching over a counter element at selected positionswhen the ampoule holder is moved into the injection device.

In some embodiments, due to the increased diameter of the septum, athicker continuation or a thicker needle can be used for injecting intothe septum, which with conventional narrow septa is only possible to arestricted extent, i.e. only possible using a thin needle. The thinneedle, however, results in an increased delivery resistance. In somepreferred embodiments, therefore, the needle unit may comprise a needlesupport from which a continuation projects in the proximal direction forpenetrating the septum and from which an injection needle projects inthe distal direction for injecting into a patient, wherein thecontinuation exhibits a larger diameter than the injection needle. Afluid channel which transports the product from the product container tothe injection needle tip can be contained in the continuation and in theinjection needle. The fluid channel can exhibit a larger fluid-guidingcross-section in the region of the continuation than in the region ofthe injection needle.

In some embodiments, in the case of the ampoule holder in which the sealand/or its radial projection is arranged or can be arranged between theampoule receptacle and the fastening member, the fastening membercomprises the engaging member which acts on the product container or canbe engaged with the product container. This can mean that a definedportion of the engaging member presses onto the product container. Theengaging member can be arranged such that it is sprung or resilientlybiased. The engaging member can thus press against the product containerwith a spring force when the fastening member is fastened to the ampoulereceptacle and thus reduce or even eliminate the axial clearance of theproduct container between the ampoule receptacle and the fasteningmember. The sprung engaging member can alternatively or additionally bepressed against the seal of the product container by a part, e.g. theneedle unit, which can be attached to the fastening member. This canalso help reduce the clearances.

In some embodiments, an arm may extend in the longitudinal direction orthe circumferential direction for arranging the engaging member suchthat it is sprung or biased, wherein the engaging member is arranged onone end of the arm, and the other end of the arm is formed, e.g.integrally, on the fastening member.

In some preferred embodiments, the fastening member, e.g. the engagingmember, can comprise a latching element which at least hinders releasingthe needle unit from the fastening member. Due to the latching element,a higher torque can be required for releasing the needle unit thanwithout the latching element. It is thus possible to prevent the needleunit which is arranged on the fastening member from beingunintentionally released.

In some preferred embodiments of the ampoule holder, the fasteningmember can be attached to the ampoule receptacle by a plugging movementor rotational movement or a combination of the two. The fastening membercan be connected or connectable to the ampoule receptacle via a thread,a longitudinal guide or a bayonet lock. The bayonet lock performs anaxial movement when it is rotated, such that the axial clearance betweenthe fastening member and the ampoule receptacle is reduced. The threadand the longitudinal guide likewise perform a longitudinal movement toreduce the clearance.

In some preferred embodiments, one of the fastening member and theampoule receptacle can comprise a latching means and the other of thefastening member and the ampoule receptacle can comprise a latchingcounter means, wherein the latching means and the latching counter meansare in engagement or can be engaged when the fastening member isfastened. This connects the fastener to the ampoule receptacle such thatit cannot be released. To reduce the axial clearance of the seal betweenthe fastening member and the ampoule receptacle, the latching means andlatching counter means can be configured such that when they mutuallyengage, the fastening member can be moved in discrete increments in thefastening direction and cannot be moved in the opposite direction. Thefastening member, e.g. the engaging member, can be moved in discretelatching increments in the direction of the seal until the fasteningmember or the engaging member presses against the seal, such that theaxial clearance of the seal is eliminated or at least reduced.

In some embodiments, the latching means or latching counter means can bearranged such that they are biased or sprung, such that they can beurged engage.

In some embodiments, the latching means can comprise at least one toothor a number of teeth, and the latching counter means can comprise atleast one tooth or a number of teeth, which are shaped such that thefastening member can be moved in one direction and cannot be moved inthe other direction. Serrated latching teeth may be used. The latchingteeth are arranged consecutively, lined up, in the fastening direction,in the circumferential direction or in the longitudinal direction.Arranging them consecutively or in a line achieves the discrete latchingincrements during fastening. It is in principle sufficient if one of thelatching means and the latching counter means comprises one tooth and/ora single tooth, and the other of the latching means and the latchingcounter means comprises a number of teeth, in accordance with thedesired number of discrete latching increments.

In one exemplary preferred embodiment, the ampoule receptacle comprisesa groove, wherein one groove flank or two groove flanks which pointtoward each other respectively comprise a latching counter means. Thefastening member comprises a latching means which is arranged such thatit is biased or sprung and is pressed against the groove flank assignedto it, into the latching counter means. In some preferred embodiments,one latching means for each groove flank is arranged on the fasteningmember.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-4 depict embodiments of components or parts of one embodiment ofa needle unit in accordance with the present invention;

FIGS. 5 and 6 depict embodiments of individual parts of embodiments ofan ampoule holder and a needle unit;

FIG. 7 depicts an embodiment of an assembled ampoule holder, togetherwith an ampoule accommodated in it;

FIG. 8 depicts the ampoule holder of FIG. 7, with a needle unit arrangedon it and on the ampoule;

FIG. 9 depicts a preferred embodiment of a fastening portion of a needleunit;

FIG. 10 depicts an exemplary preferred embodiment of an administeringdevice in accordance with the present invention;

FIGS. 11 a-11 d are a number of views of an exemplary preferredembodiment of a fastening member in accordance with the presentinvention;

FIG. 12 depicts a preferred embodiment of an ampoule holder comprising aneedle unit and the fastening member if FIGS. 11 a-11 d;

FIG. 13 includes a number of views of an embodiment of an ampoulereceptacle in accordance with the present invention, comprising afastening member;

FIG. 14 includes a number of views of another embodiment of an ampoulereceptacle and a fastening member; and

FIG. 15 depicts another embodiment of an ampoule receptacle and afastening member.

DETAILED DESCRIPTION

With regard to fastening, mounting, attaching or connecting componentsof the present invention, unless specifically described as otherwise,conventional mechanical fasteners and methods may be used. Otherappropriate fastening or attachment methods include adhesives, weldingand soldering, the latter particularly with regard to the electricalsystem of the invention, if any. In embodiments with electrical featuresor components, suitable electrical components and circuitry, wires,wireless components, chips, boards, microprocessors, inputs, outputs,displays, control components, etc. may be used. Generally, unlessotherwise indicated, the materials for making embodiments of theinvention and/or components thereof may be selected from appropriatematerials such as metal, metallic alloys, ceramics, plastics, etc.Unless otherwise indicated specifically or by context, positional terms(e.g., up, down, front, rear, distal, proximal, etc.) are descriptivenot limiting. Same reference numbers are used to denote same parts orcomponents.

Referring to FIGS. 1-4, a device in accordance with the presentinvention comprises a needle unit having a number of elements or parts6, 7, 8, 10 which form a fluid channel which may also be referred to asa fluid-guiding channel. More generally, the parts forming the fluidchannel are: a continuation 2, which may also be referred to as apiercing means; a needle support 1, which may also be referred to as acannula support; and an injection needle 3, which may also be referredto as a cannula tube.

The hollow, cylindrical injection needle 3 exhibits a constant outerdiameter D₃ and a constant inner diameter. At its distal (or forward orfront) end, there is a cutting tip which is asymmetrical in the sectionshown. The injection needle 3 serves for injecting into the skin of apatient and is fastened via its proximal (rear) end to the needlesupport 1. The fastening shown here consists of a part of the injectionneedle being accommodated in a hollow-cylindrical bore 5, the innerdiameter of which approximately corresponds to the outer diameter of theneedle 3. The needle 3 could in principle be pressed or molded in thehollow cylindrical portion of the needle support 1, for example when theneedle support 1 is manufactured by injection molding. In someembodiments, the needle is adhered into or on the needle support 1. Toprevent stress peaks when transverse forces are exerted on the needle 3,the portion 5 is connected to an expanding region, e.g. a region whichexpands in the shape of a trumpet, which extends as far as the distalend of the needle support 1, as shown here. Alternatively oradditionally, this region can also serve to accommodate adhesive for anadhesive connection between the needle support 1 and the needle 3. Theneedle 3 may be fastened to the needle support 1 such that it cannot bereleased. In some embodiments, the needle 3 is made of a metal which issuitable for injection needles, and the needle support 1 is made ofplastic.

The needle support 1 comprises a portion 8 of the fluid channel which isconnected to the proximal end of the injection needle 3. The portion 8can be hollow and cylindrical. In particular, the portion 8 exhibitsapproximately the same fluid-guiding cross-section, e.g. the same innerdiameter, as the injection needle 3. This configuration reduces the riskof turbulence or a turbulent flow when fluid transitions from theportion 8 into the portion 10 of the injection needle 3.

The needle support 1 also comprises a portion 7 of the fluid-guidingchannel, which exhibits a larger fluid-guiding cross-section than theportions 8 and 10 of the fluid-guiding channel. The portion 7 tapers inthe direction of the injection needle 3, i.e. the fluid-guidingcross-section is reduced in the portion 7 in the direction of the needle3. The fluid-guiding cross-section can be reduced at a constant rate,i.e. a constant gradient, or—as shown here—at an increasing and/ordecreasing gradient. In the direction of the injection needle 3, thefluid-guiding cross-section is initially reduced at an increasinggradient. Subsequently, the fluid-guiding cross-section tapers at adecreasing gradient. In a longitudinal section, the portion 7 of thefluid channel can exhibit a concave and/or convex curve of the channelwall. In the direction of the injection needle 3, the wall of theportion initially exhibits a concave curve and subsequently a convexcurve. The transitions between the individual portions, for example thetransition from concave to convex, can be embodied to be continuous orat least to have no sharp edges. The same applies to the transition ofthe portion 7 into the portion 8.

The needle support comprises a shaft, for example a cylindrical shaft,which extends in the distal direction and in which the needle 3 isarranged and fastened.

The needle support 1 is connected via a join or connection 9 to thecontinuation 2. The join or connection can be a force-fit, material-fitor positive-fit connection. The join or connection is fluid-proof. Asuitable join or connection can be achieved by adhering, pressing,latching or fusing.

The continuation 2 which is connected to the needle support 1 comprisesa portion 6 of the fluid-guiding channel. The portion 6 expands in thedirection of the injection needle 3, for example in the shape of afunnel or cone. A measure of the expansion can be a conical angle ofapproximately 4°, to cite just one example. The conical angle can rangefrom 1° to 45°. In some preferred embodiments, rather smaller conicalangles may be preferred.

In some preferred embodiments, the portion 6 opens into the portion 7when the needle support 1 is connected to the continuation 2. Theportions 6 and 7 can respectively exhibit an identical fluid-guidingcross-section, e.g. an identical inner diameter, at the aperture.

The portion 6 can exhibit a cross-sectional ratio of its maximumfluid-guiding cross-section to its minimum fluid-guiding cross-sectionof 4:1. Cross-sectional ratios of 2:1 to 10:1 have proven to beadvantageous. The ratio can also be 2.5:1 or other suitable ratio.

The fluid to be administered is supplied from the environment of thecontinuation 2 to the fluid channel via an opening 4. Although oneopening 4 would in principle be sufficient, two openings 4 are shown inthe depicted example, which are arranged opposite each other and on theside of the fluid channel 6. A part of the fluid channel 6 is thusarranged between the openings 4. The openings 4 have the shape of anelongated hole which can be between 1 and 4 mm long, e.g. 3 mm, and canexhibit a width of the diameter of the part of the fluid channel 6 whichis arranged between the openings. The overall cross-sectional area ofthe openings 4, or one of them, can be larger than the minimumfluid-guiding cross-section of the portion 6. The ratio of the overallcross-sectional area of the openings 4 and the minimum fluid-guidingcross-section of the portion 6 can be 7:1. The overall cross-sectionalarea of the openings 4 should be at least as large as the minimumfluid-guiding cross-section. The cross-sectional ratio can range from2:1 to 10:1 and to other suitable ratios.

The continuation 2 comprises a rotationally symmetrical tip which isembodied in this example as a cone and forms the distal end of thecontinuation 2. The arrangement of the two openings 4 causes the fluidto be supplied laterally, i.e. transverse to the longitudinal axis, andsubsequently transported in the fluid-guiding channel (which may bethought of as comprising elements or portions 6, 7, 8, 10) along thelongitudinal axis in the direction of the needle 3.

The continuation 2 comprises a connecting portion 12 using which theunit consisting of the needle support 1, the continuation 2 and theneedle 3 can be connected, indirectly or directly as applicable, to apart of the injection device. Alternatively, the needle support 1 couldcomprise the portion 12.

In the region of the fluid channel portion 7, the proximal end of theneedle support 1 comprises a recess which is surrounded by an annularprotrusion. In this example, the annular protrusion is concentric withthe longitudinal axis of the needle unit 100. The distal end of thecontinuation 2 exhibits a shape which approximately corresponds to anegative mold of the proximal facing side of the needle support 1. Thedistal facing side of the continuation 2 comprises an annular grooveinto which the annular protrusion is arranged when the continuation 2 isjoined together with the needle support 1, and comprises a truncatedconical protrusion which engages with the recess of the needle support 1when the continuation 2 and the needle support 1 are joined together.This achieves join or connection 9 which is fluid-proof. The mutualengagement of the two facing sides increases the surface which can beused for a connection 9.

The injection needle 3 can be selected from needles having a wide rangeof diameters, wall thicknesses and lengths; for example, it is equallypossible to provide a 23 gauge needle or a 31 gauge needle. Theinjectable length of the injection needle 3 can be selected for asubcutaneous or transcutaneous injection.

A needle unit 100 is shown in FIGS. 5 and 6. The unit, comprising theneedle support 1, the continuation 2 and the injection needle 3, isconnected to a fastening portion 13 via the connecting portion 12. Thesleeve-shaped fastening portion 13 serves to be connected to a fasteningmember 20 and comprises a thread, e.g. an outer thread, for thispurpose. The unit forming the fluid channel (which, again, may bethought of and/or referred to as comprising elements, parts or portions6, 7, 8, 10) is connected, axially fixed, to the fastening portion 13.Depending on its application, the unit 100 can be rotatable ornon-rotatable relative to the fastening portion 13. The unit furthercomprises a connecting protrusion 12 a which engages with an annulargroove 13 c formed on the inner circumference of the fastening portion13. The fastening portion 13 is connected such that it is rotationallyand axially fixed to a casing 14. The fastening portion 13 and thecasing 14 could in principle also be formed integrally, however formingthem in a number of parts has advantages when manufacturing the needleunit 100. The sleeve-shaped casing 14 surrounds both the fasteningportion 13 and the continuation 2 and its tip on the circumferentialside. The casing 14 extends in the proximal direction, at least as faras the tip or—as shown here—beyond the tip, such that the tip of thecontinuation 2 does not protrude beyond the proximal end of the casing14. The risk of unintentional piercing by the tip of the continuation 2is reduced by the casing 14 protruding beyond the tip 2. An annular gapis formed between the fastening portion 13 and the casing 14. The casing14, the fastening portion 13 and the unit 100 are arrangedconcentrically with respect to each other.

The distal end of the casing 14 comprises a facing area comprising anopening through which the injection needle 3 protrudes by a length. Thislength substantially corresponds to the injection depth of the injectionneedle 3, since the distal end of the casing forms an abutment area forthe patient's body. For reasons of space, the casing 14 can comprise acavity for the needle support 1.

The needle unit 100 also comprises a packaging sleeve 15 which in theposition shown in FIGS. 5 and 6 is arranged concentrically over theouter circumference of the casing 14. The packaging sleeve 15 is held bythe casing 14, e.g. in a frictional fit. The packaging sleeve 15surrounds the casing 14 completely over its circumference and also overits length. In some preferred embodiments, the packaging sleeve 15proximally protrudes at least slightly beyond the proximal end of thecasing 14. The opening which is formed at the proximal end of thepackaging sleeve 15, through which the casing 14 together with the unit100 can be inserted or removed, can be sealed with a so-called peel filmin the delivered state of the needle unit 100, to keep the contents ofthe packaging sleeve 15 sterile or at least to protect them fromcontamination. The packaging sleeve 15 distally protrudes beyond thedistal end of the needle 3, where it is sealed on its facing side. Inthis respect, the packaging sleeve 15 forms a closed cup which comprisesan opening at its proximal end. The outer circumference of the packagingsleeve 15 comprises a structure which better enables a user of thedevice to apply a torque to the packaging sleeve 15, about thelongitudinal axis. Since, when completely placed on the casing 14, thepackaging sleeve 15 is connected, such that it is rotationally fixed, tothe casing 14 at least in a frictional fit, and alternatively oradditionally in a positive fit, the casing 14 together with thefastening portion 13 is rotated along with the packaging sleeve 15 whena torque is applied to the packaging sleeve 15.

The needle unit 100 can be attached to an injection device 50 (FIG. 10).Parts of the injection device, namely an ampoule receptacle 30 and afastening member 20, are shown separately together with an ampoule 40 inFIGS. 5 and 6, assembled in FIG. 7 and assembled with a needle unit 100attached in FIG. 8.

The ampoule 40, such as is shown for example in FIGS. 5 and 6, is aso-called two-chamber ampoule (which may also be referred to as atwo-chamber carpoule), one characteristic of which is that a product tobe administered is merged or mixed, directly before being administered,from two components which for storage are contained in two differentchambers. The distal chamber, i.e. the chamber which is arranged betweena seal (comprised of parts 41, 42, 43, 44) and a first plunger 45, can,for example, be partially or completely filled with a solid such as agranular or powdery material. A second chamber is situated proximallywith respect to the first plunger 45 and is arranged between the firstplunger 45 and a second plunger 46. A fluid constituent of the drug canbe situated in this chamber. Both plungers 45, 46 abut ahollow-cylindrical casing portion 48 of the ampoule 40, forming a seal,and can be shifted along the casing portion 48.

In the region of the casing portion, the ampoule 40 comprises aso-called bypass 47 which forms a camber outwardly. The bypass 47 isaxially longer than the first plunger 45.

For mixing, a pressure is exerted in the distal direction on the secondplunger 46 and transferred onto the first plunger 45 via the fluidproduct in the chamber between the plunger 45 and the plunger 46. Whenthe second plunger 46 is shifted in the distal direction, the firstplunger 45 is thus also shifted, as far as the region of the bypass 47.Due to the camber of the bypass 47, it is possible—providing the plunger45 is situated completely in the region of the bypass 47—for the fluidproduct to flow past the plunger 45 and into the distal chamber and tomix with the product constituent situated therein. The user can assistmixing by shaking the device. The fluid product has been completelyremoved from the proximal chamber when the second plunger 46 abutsagainst the first plunger 45. The mixture consisting of the two productconstituents can form a homogeneous or a heterogeneous mixture. Theheterogeneous mixture of a fluid constituent with particles of solid isgenerally referred to as a dispersion, specifically a suspension. Theproduct to be administered can then be delivered via the fluid channelof the needle unit 100, the openings 4 of which are situated within theampoule, such as for example in the region 42, by shifting the plungers45 and 46 in the distal direction along the hollow-cylindrical casingportion 48.

The ampoule 40 comprises a seal (which, again, may be thought of and/orreferred to as being comprised of elements 41, 42, 43, 44) whichcomprises a septum 41 which can be penetrated by the continuation 2.Such septa can be made of rubber or natural rubber or another suitablesynthetic material.

The septum 41 comprises a disc-shaped portion and a hollow-cylindricalportion connected to it in the proximal direction. Thehollow-cylindrical portion forms a cavity in its interior, in which theopenings 4 of the completely attached needle unit 100 are positioned insome preferred embodiments. The outer side of the hollow-cylindricalportion of the septum 41 centers the septum 41 on the innercircumference of the ampoule 40, e.g. at the distal end of the ampoule40. An annularly circumferential bulge is formed at the distal end ofthe ampoule 40 and protrudes radially outwardly and may be referred togenerally as a projection. The bulge 43 protrudes radially beyond theouter circumference of the hollow-cylindrical portion 48 of the ampoule40. In other words, the ampoule 40 exhibits a larger outer diameter atthe point of the bulge 43 than in the region of the hollow-cylindricalportion 48. In this example, the outer diameter of the bulge 43 alsoforms the maximum outer diameter of the ampoule 40. The bulge 43 isintegrally connected to the hollow-cylindrical portion 48. This part ofthe ampoule can be formed from plastic or glass. The disc-shaped part ofthe septum 41 exhibits approximately the same outer diameter as thebulge 43. The septum 41 and the bulge 43 are held together by a remoldedor deformable part 44 which can be produced from a metal sheet. Thispart may also be referred to as a cap. The remolded part 44 clasps theseptum 41 and the bulge 43 over their circumference and both distallywith respect to the septum 41 and proximally with respect to the bulge43. The remolded part 44 connects the bulge 43 and the septum 41 suchthat they are axially fixed, i.e. holds them together in a fluid seal.The distal facing side of the remolded part 44 comprises an openingwhich can be circular and through which the continuation 2 can beinserted through the septum 41 into the interior of the ampoule 40 whichhas already been mixed.

Between the hollow-cylindrical part 48 and the bulge 43, the ampoule 40comprises a neck which is constricted relative to the outer diameter ofthe portion 48, such that the remolded part 44 can be reformed even morecompletely, e.g. further inwardly, around the proximal end of the bulge43. The proximal end of the ampoule 40 is open, such that a plunger rod52 (FIG. 10) can be slid into the ampoule 40 and onto the second plunger46.

The fastening member 20 can be fastened to the ampoule receptacle 30.The fastening member 20 and the ampoule receptacle 30 may be thought ofand/or referred to as the ampoule holder. The fastening member 20 issleeve-shaped and connected, e.g. latched, to the ampoule receptacle 30such that it is rotationally and axially fixed. The rotational fixationis achieved by the engagement between the cavity 23 and the cam 34. Theaxially fixed arrangement of the fastening member 20 on the ampoulereceptacle 30 is achieved by the cam 32 latching into the windows 22.

As can be seen from FIGS. 5 and 6, the ampoule 40 is inserted into theampoule receptacle 30 via a distal opening of the sleeve-shaped ampoulereceptacle 30. The outer diameter of the seal is larger than the innerdiameter of the ampoule receptacle 30, such that the seal abuts thedistal end of the ampoule receptacle 30. As can be seen from FIG. 7, theseal of the ampoule 40 is axially enclosed between the ampoulereceptacle 30 and the fastening member 20 and thus axially fixed. Theenclosure can allow the ampoule 40 a small axial clearance. However, theenclosure may be such that the axial clearance is further reduced. Tothis end, the distal end of the ampoule receptacle 30 comprises at leastone projection—in this case, four projections 35—which extend in thedistal direction and which the seal abuts. The at least one projection35 can be arranged on the ampoule holder, e.g. on the ampoulereceptacle, rigidly as shown here or such that it is loaded or biased.Arranging it loaded has the additional advantage that an axial clearanceis virtually no longer present. The loading arrangement can be achievedby providing a slit, which extends in the circumferential direction,proximally with respect to the at least one projection 35, such that thestay which is situated between the slit and the projection 35 can besprung in the axial direction.

The seal can be enclosed from the distal side by a collar formed on theinner circumference of the fastening member 20. The collar can partiallyor completely encircle the circumference. A projection 28 which extendsinwardly from the inner circumferential area is provided, either as analternative to or in addition to the collar, and can serve as anenclosure for the seal. On its side pointing toward the seal, theprojection 28 comprises a projection, e.g. a cam 27, which pressesagainst the distal facing area of the seal, against the remolded part44. A part of the seal, such as the remolded part 44, can be elasticallyor plastically deformed by the point-focussed burden of the cam 27, thusachieving a secure, low-clearance enclosure of the seal between theampoule receptacle 30 and the fastening member 20. The cam 27 can bearranged rigidly or such that it is urged in the longitudinal direction.

As can be seen from FIGS. 5 to 7, the outer circumference of the ampoulereceptacle 30 comprises an outer thread 33 via which the ampoule holdercan be screwed into a casing 51 of the injection device 50 (FIG. 10),wherein the casing 51 comprises a corresponding inner thread for theouter thread 33 of the ampoule holder. To make the intuitive handling ofthe device 50 easier for the user, at least one arrow can be arranged onthe ampoule holder, e.g. on the circumference of the ampoule receptacle30, which points in the direction of rotation for mixing the device. Insome preferred embodiments, a multitude of arrows are distributed overthe length of the ampoule receptacle 30. The arrows can be printed on orformed as elevations or recesses which are molded as the ampoulereceptacle 30 is injection-molded. The at least one arrow can bearranged between adjacent flights of the thread 33.

The ampoule holder, e.g. the ampoule receptacle 30, also comprises alatching member 36 which is mounted such that it is biased in the radialdirection. The springiness or resiliency is generated by an arm whichextends in the circumferential direction and which is formed on theampoule receptacle 30 and on which the latching member or cam 36 isformed. The function of said latching member 36 is described below withreference to FIG. 10.

The fastening member 20 also comprises a single-flight ormultiple-flight thread—in this example, in the form of two threadedportions 21 which enable the needle unit 100, comprising the outerthread situated on the fastening portion 13, to be screwed onto theinjection device. Due to the axial movement of the continuation 2 whenthe needle unit 100 is screwed on, the tip of the continuation 2penetrates the septum 41. The torque required for screwing on the needleunit 100 is applied via the packaging sleeve 15 or the casing 14. Oncethe needle unit 100 has been completely screwed on, it assumes theposition shown in FIG. 8. The openings in this case are then situatedwithin the ampoule 40, such that the distal end of the injection needle3 is fluidically connected to the interior of the ampoule 40. A distalportion of the fastening member 20 is then situated in the annular gapbetween the fastening portion 13 and the casing 14.

Providing the unit 100 is arranged such that it can be rotated relativeto the fastening portion 13, it is possible for the continuation toinject into the septum 41 with a purely axial movement. This can offeradvantages with regard to the seal between the septum and thecontinuation. If the unit is arranged such that it is rotationally fixedrelative to the fastening portion 13, the septum is penetrated by thecontinuation 2 by means of a combined rotational and axial movement,which offers advantages with regard to the torque required for screwingon the needle unit 100.

As can be seen from FIGS. 5 and 9, the fastening member 20 comprises anabutment 26 which acts in the circumferential direction, and thefastening portion 13 comprises an abutment 13 a which likewise acts inthe circumferential direction. A number of such abutments—such as twosuch abutments in this example—can also be arranged on each of thefastening member 20 and the fastening portion 13.

The abutments 26 and 13 a form an abutting pair and are positioned suchthat they pass into a rotational abutment when the needle unit 100 is inits completely screwed-on position (FIG. 8), thus securely preventingany further rotation. The abutment 13 a is formed on the proximal end ofthe fastening portion 13. The abutment 26 is formed on the projection 28of the fastening member 20. An axial abutment could also optionally beprovided instead of a rotational abutment, however the rotationalabutment has the advantage over an axial abutment that the parts whichpass into abutment are not burdened as much, since due to thetranslation generated by the thread pitch, a significantly greater forcecan be achieved by a particular torque in the axial direction than inthe circumferential direction.

The fastening member 20 can comprise one or more projections 24 or 25which latch to the needle unit 100 shortly before the rotationalabutment is reached, such that a reverse rotation of the needle unit 100in the opposite direction is only possible using an increased torque oris not at all possible, i.e. is only possible by destroying a componentor a part of a component. Alternatively, cavities which serve the samepurpose can be provided instead of the projections 24, 25. Due to thelatching when the needle unit 100 is screwed on, the user obtains on theone hand a tactile signal which indicates to him/her that the needleunit 100 has then been completely screwed on. On the other hand, itprevents an unintentional reverse rotation, such that the risk ofmisapplication can be reduced. Where cavities or cams 24 are provided asthe reverse rotation block, these engage with the casing 14 of theneedle unit 100, with its facing side formed in the annular gap. Forthis purpose, the facing side can comprise at least one projection—suchas for example ribs or a cam—or a cavity, which is traversed shortlybefore or when the rotational abutment is reached.

A projection 25 can alternatively or additionally be provided in theform of a cam which protrudes in the distal direction and traverses aprojection 13 b, e.g. a cam, shortly before or when the rotationalabutment is reached. The projection 13 b is arranged on the proximalfacing side of the fastening portion 13 and, offset in thecircumferential direction, in front of the abutment 13 a. The distancebetween the projection 13 b and the abutment 13 a can correspondapproximately to the width of the projection 25 as measured in thecircumferential direction, which means that the cam 25 is held betweenthe abutment 13 a and the projection 13 b when the needle unit 100 iscompletely screwed on.

A projection 13 b which allows a screwing movement counter to thescrewing-on direction can comprise flanks which are flattened on bothsides in the circumferential direction. A projection 13 b which isintended to prevent a rotation counter to the screwing-on direction frombeing possible can exhibit the shape of a serrated tooth which allowsthe projection 13 b to be traversed but prevents a reverse rotation dueto the steep area of the serrated tooth. The same applies of course tothe latching between the cavities or projections 24 and the cavities orprojections on the casing 14.

The projection 13 b is arranged on the facing side of the fasteningportion which is embodied as a helical rail. The helical shape exhibitsapproximately the pitch of the thread of the fastening portion 13.

A preferred embodiment of an injection device in accordance with thepresent invention is shown in FIG. 10. The device is a mixing anddelivering device 50 which for the sake of simplicity is referred to inthe following as an injection device. The injection device 50 comprisesa casing 51 comprising an inner thread into which the ampoule holdershown in FIG. 7, which comprises an outer thread 33, can be screwed. Aplunger rod 52 is arranged within the sleeve-shaped casing 51 and isconnected to an injection button 58. When the injection device 50 is inits initial state, i.e. before the product constituents of thetwo-chamber ampoule 40 have been mixed, the injection button 58 issurrounded over its axial length, e.g. completely, by the casing 51. Twowings 57 which point radially outwardly are arranged on the casing 51.The small plate-shaped wings make it easier for the user to hold thedevice and apply a necessary torque when mixing. The wings 57 thus serveas a gripping aid and, in combination with a gripping portion 29,improve the intuitively correct handling. The wings 57 are situated atthe proximal (rear) end of the device 50.

In one preferred embodiment, the injection device comprises an outersleeve 29 which serves as a gripping portion and which the user of thedevice 50 can clasp in one hand, while he or she screws the casing 51onto the ampoule holder, into the annular gap formed between the outersleeve 29 and the ampoule receptacle 30, with the other hand at thewings 57. This has the advantage that it allows patients who haverestricted motor abilities to securely mix the product constituents. Atthe end of the mixing sequence and as applicable a priming sequence, theabutment 29 a formed at the proximal end of the outer sleeve 29 and theabutment 54 a formed by the casing 51 in the region of the distal endpass into a rotational or axial abutment, such that this indicates tothe user that the mixing process and priming process are complete.

In an alternative, also preferred embodiment, the injection device 50 iswithout the outer sleeve 29. The user of the injection device can claspthe packaging sleeve 15 or the casing 14 with one hand and the casing 51or as applicable wings 57 fastened to it with the other hand, to applythe torque. Mixing is analogous relative to the embodiment comprising asleeve-shaped gripping portion 29, wherein the end of the mixing processis indicated by the rotational or axial abutment of the distal end ofthe casing 51 against the annularly circumferential collar of theampoule holder which is indicated in FIG. 5 by the reference sign 31.This variant is also possible, in the embodiment comprising an outersleeve 29. Due to the rotational abutments 26, 13 a between the needleunit 100 and the ampoule holder, it is possible to securely prevent thecomponents involved in the abutment from being overloaded, even when thetorque for mixing passes via the needle unit 100.

In both exemplary embodiments of an injection device 50, it is the casethat when the ampoule receptacle 30 and the casing 51 are screwed intoeach other when mixing the product constituents, the plunger rod 52passes into abutment with the plunger 46, thus moving the casing 51 inthe distal direction relative to the plunger rod 52, wherein the plungerrod 52 remains axially fixed relative to the ampoule 40 due to thestatic friction between the plunger/plungers 45, 46 and the ampoulewall. The plunger rod 52 comprises a cavity, on the distal end 53 ofwhich an abutment 53 is formed. While the ampoule receptacle 30 is beingscrewed into the casing 51, the axial abutment 56 which is formed by thecasing 51 is moved in the direction of the abutment 53. The injectionbutton 58 protrudes proximally out of the casing 51 during thismovement. As soon as the abutment 56 abuts against the abutment 53, theplunger rod 52 is slaved such that the plunger rod 52 participates inthe axial movement of the casing 51 in the distal direction relative tothe ampoule receptacle 30 and relative to the ampoule 40. The plungerrod 52 can then shift the plunger 46 in the distal direction, thusperforming the mixing sequence such as has been described further above.At the end of mixing, the latching member 36 can engage with or traversea latching element 54, which can indicate the end of the mixing processto the user. The user then shakes the device 50, such that the productconstituents are mixed. The user can subsequently prime the device toremove from the ampoule 40 any air which may still be contained in theampoule 40. For this purpose, the user can continue the screwingmovement of the casing 51 relative to the ampoule receptacle 30, whereinboth plungers are then shifted and the volume in the product containeris reduced, thus expelling the air from the product container 40 via thefluid channel of the needle unit 100. At the end of the primingsequence, the latching member 36 can latch into another latching element55, likewise formed on the inner circumference of the casing 51, thusindicating the end of the priming sequence to the user. The device 50 isthen ready for a product delivery which, after the needle 3 has beeninjected into a desired point on the body, is initiated by pressing theinjection button 58 in the distal direction relative to the casing 51and relative to the ampoule 40.

The latching elements 54 and 55 can be formed such that an acoustic ortactile signal is generated during an interaction, e.g. when thelatching member 36 traverses the latching elements 54 and 55. By formingthe flanks on the latching member 36 to be asymmetrical in thecircumferential direction, it is also possible that once the latchingmember 36 has reached the latching elements 54 or 55, any furtherrotation in a direction counter to the mixing or priming movement is nolonger possible.

In the embodiment comprising an outer sleeve 29, the latter can beconnected to the ampoule receptacle 30 such that it is rotationally andaxially fixed, for example by a latching connection or by forming itintegrally with the ampoule receptacle 30 or the fastening member 20.The outer sleeve 29 can extend from the fastening member 20 far enoughin the proximal direction that its proximal end proximally protrudesbeyond the proximal end of the ampoule 40 and also beyond the proximalend of the product container receptacle 30.

The embodiment shown in FIG. 10 has the advantage that the user of thedevice 50 does not see any thread, which may be advantageous in the caseof people who regard technology with skepticism. A color coding may begiven on the outer side of the casing 51, from which it is additionallypossible to optically tell whether the device is being mixed or primedor whether the device is ready for a product delivery. A first color canbe arranged such that it is covered by the first sleeve 29 after mixingis complete. A second, different color can also be provided whichdisappears beneath the second sleeve 29 after priming. A third color canthen be provided which indicates to the user that the device is thenready for a product delivery. To improve the grip, the outer sleeve 29can be provided with a friction-increasing structure, for example ribsor pimples, or a friction-increasing material such as a rubber layer.The same also applies to the wings 57.

FIGS. 11 a and 11 d show a preferred embodiment of a fastening member20. In FIG. 12, the fastening member 20 shown in FIGS. 11 a to 11 d isfastened to or carried by the ampoule receptacle 30, wherein the needleunit 100 is arranged on the fastening member 20.

The fastening member 20 can be connected to the ampoule receptacle 30using one of the options described here, which are exemplary of suitableoptions. The fastening member 20 comprises a thread 21 which is anexample of a way of fastening the needle unit 100 to the fasteningmember 20. Alternatively, ways of fastening the needle unit 100 whichare described here or which are known from the prior art can beprovided. The fastening member 20 comprises at least one—in this case,four—engaging members 20 a which are each arranged on an arm such thatthey are sprung, or urged or biased. The arm extends in thecircumferential direction, is connected at one end—e.g. integrally—tothe fastening member 20, and comprises the engaging member 20 a at itsother end, i.e. its free end. As can best be seen from FIG. 12, theengaging member 20 a is pressed against the distal (forward) end of theproduct container 40, i.e. against the seal (which again, may be thoughtof and/or referred to as made up of elements 41, 43, 44), when theneedle unit 100 is fastened to the fastening member 20. For thispurpose, the needle unit 100 comprises an area which points in theproximal direction and presses against the engaging member 20 a. At thelatest after or when the needle unit 100 is attached to the ampouleholder the seal of the product container 40 is enclosed, with noclearance, between the ampoule receptacle 30 and the fastening member20, e.g. the engaging member 20 a. The seal of the product container 40can have a slight axial clearance before the needle unit 100 isattached. Even before the needle unit 100 is attached, this axialclearance can be reduced or even eliminated by the engaging member 20 apressing against the seal in such a way that it is sprung. The attachedneedle unit 100 holds the engaging member 20 a in abutment with thedistal facing side of the seal.

The fastening member 20, e.g. the engaging member 20 a, can comprise aprojection 20 b which protrudes distally beyond the facing side of thefastening member 20. This enables the engaging member 20 a to pressagainst the seal of the product container 40. The projection 20 b cansolely or additionally have the effect of the projections 24 or 25 shownfor example in FIGS. 5 and 6, to which reference is hereby made. Theneedle unit 100 can of course comprise the corresponding elements suchas are described for the co-operation with the projections 24 or 25.

FIGS. 13 and 14 show embodiments in which the fastening member 20 isplugged onto the ampoule receptacle 30 by an axial movement, without arotational movement, and latched to the ampoule receptacle 30. Thelatching device is formed such that the fastening member 20 which islatched to the ampoule receptacle 30 can be shifted in the fasteningdirection or plugging direction and cannot be shifted in the oppositedirection. Thus, once it is latched to the ampoule receptacle 30, thefastening member 20 can no longer be removed from the ampoule receptacle30 but can be slid on further, wherein the fastening member 20 latchesfurther in the plugging direction in discrete increments. The axialclearance which the seal of the product container 40 has between theampoule receptacle 30 and the fastening member 20 can be reduced witheach latching increment, until a latching position is eventually reachedin which the fastening member 20 presses against the seal of the productcontainer 40. This encloses the seal with no axial clearance.

In some embodiments, the fastening member 20 comprises a latch structureor latching means 20 c as its latching device and the ampoule receptacle30 comprises a complementary latch member or latching counter means 30 cas its latching device, wherein the latching means 20 c and the latchingcounter means 30 c mutually engage for the latching connection. In theexample shown in FIG. 13, the latching counter means 30 c is arranged onan arm, such that it is sprung or urged, while the latching means 20 cis arranged approximately rigidly on the fastening member 20. In theexample shown in FIG. 14, the latching means 20 c is arranged on an arm,such that it is sprung, and the latching counter means 30 c is arrangedsubstantially rigidly on the ampoule receptacle 30.

The latching means 20 c and latching counter means 30 c comprise anumber of serrated teeth or other suitable structures which are arrangedin succession in the axial direction and are complementary and/ormutually engageable. It is in principle sufficient if one of thelatching means 20 c and the latching counter means 30 c comprises onetooth and the other of the latching means 20 c and the latching countermeans 30 c comprises a number of teeth, wherein for increased stability,the latching means 20 c and the latching counter means 30 c eachcomprise a number of mutually engaging teeth. The distal region of theampoule receptacle 30 shown in FIG. 13 comprises centering areas and thearm comprising the latching counter means 30 c, wherein the centringareas radially center the fastening member 20. The latching countermeans 30 c is arranged on the outer side, e.g. protruding radiallyoutwardly, on the ampoule receptacle 30.

The ampoule receptacle 30 shown in FIG. 14 comprises a groove 30 awhich, extends in the longitudinal direction and is laterally enclosedby groove flanks 30 b. The groove flanks 30 b each comprise a latchingcounter means 30 c, wherein the latching counter means 30 c is directedfrom one groove flank 30 b toward the other groove flank 30 b. Thefastening member 20 comprises two latching means 20 c, each arranged onan arm, which can be sprung or urged toward and away from each other.The ampoule receptacle 30 comprises a centering area which radiallycenters the fastening member 20 as it is plugged on. As the fasteningmember 20 is plugged on, the latching means 20 c and latching countermeans 30 c pass into engagement, wherein the latching means 20 c arepressed toward each other by the groove flanks 30 b, wherein the sprungor resilient arrangement presses the latching means 20 c into engagementwith the latching counter means 30 c. This achieves a stable fastening.The arms which bear the latching means 20 c could in principle extend inthe proximal direction from the fastening member 20, wherein thelatching means 20 c is arranged on the proximal end of the arm. Anotherarrangement is shown in FIG. 14, wherein the sprung arms are formed atthe proximal end of an arm which extends in the proximal direction fromthe fastening member 20. The sprung arms extend in the distal directionfrom the proximal end of one arm, wherein the latching means 20 c isarranged on the distal end of the sprung arm.

FIG. 15 shows another preferred exemplary way of fastening the fasteningmember 20 to the ampoule receptacle 30. As opposed to the embodimentsfrom FIGS. 13 and 14, the fastening is based on a plug-rotationconnection instead of a purely axial plug connection. This plug-rotationconnection is generally also referred to as a bayonet lock (comprisingelements 20 f, 30 f). For the bayonet lock, the inner circumference ofthe fastening member 20 comprises a groove-shaped guiding track 20 finto which a cam 30 f of the ampoule receptacle 30 which protrudesradially outwardly can be inserted. The fastening member 20 is fastenedby rotating it relative to the ampoule receptacle 30. The fasteningmember 20 also performs a longitudinal movement as it is rotated, suchthat the seal of the product container 40 (not shown) is enclosed, withno clearance, between the ampoule receptacle 30 and the fastening member20. To prevent the fastening member 20 from being released from theampoule receptacle 30, the ampoule receptacle 30 comprises a latchingcounter means 30 c which is formed, such that it is resilient, on an armwhich extends in the circumferential direction, wherein the latchingcounter means 30 c can engage with the latching means 20 c which isformed on the inner circumference of the fastening member 20. As in theembodiments of FIGS. 13 and 14, the latching means 20 c and the latchingcounter means 30 c comprise serrated teeth, wherein the teeth arelikewise arranged successively in a line in the fastening direction.Since the fastening direction is a rotational movement in the embodimentfrom FIG. 15, the teeth are lined up and/or arranged successively in aline in the circumferential direction. Alternatively, of course, athreaded or other suitable coupling arrangement can be provided for thefastening instead of a bayonet lock.

Embodiments of the present invention, including preferred embodiments,have been presented for the purpose of illustration and description.They are not intended to be exhaustive or to limit the invention to theprecise forms and steps disclosed. The embodiments were chosen anddescribed to illustrate the principles of the invention and thepractical application thereof, and to enable one of ordinary skill inthe art to utilize the invention in various embodiments and with variousmodifications as are suited to the particular use contemplated. All suchmodifications and variations are within the scope of the invention asdetermined by the appended claims when interpreted in accordance withthe breadth they are fairly, legally, and equitably entitled.

The invention claimed is:
 1. An ampoule holder for an ampoule, theampoule having a central, longitudinal axis and comprising a seal with aseptum and a radial projection in a plane perpendicular to the central,longitudinal axis, the ampoule holder comprising: an ampoule receptacleconfigured to receive the ampoule within an interior via a distal end ofthe ampoule receptacle, said distal end comprising an inner diameterthat is smaller than an outer diameter of the radial projection of theseal such that the radial projection cannot be received within theampoule receptacle interior; and an injection needle fastening memberconnectable to the ampoule receptacle, wherein the radial projection canbe arranged between the distal end of the ampoule receptacle and thefastening member, with the ampoule receptacle and the fastening memberhaving in common the central, longitudinal axis, wherein one of theampoule receptacle and the fastening member comprises a latch and theother of the ampoule receptacle and the fastening member comprises acounter latch for engaging the latch, wherein when the latch and thecounter latch are engaged, relative movement between the latch and thecounter latch is possible only in an axial fastening direction, andwherein as the fastening member and the ampoule receptacle are latchedin the fastening direction, an axial clearance of the seal between thefastening member and the distal end of the ampoule receptacle is reducedor eliminated and the distal end of the ampoule receptacle abuts aproximal end of the radial projection of the ampoule.
 2. The ampouleholder according to claim 1, wherein the fastening member comprises anengaging member which acts on the ampoule seal.
 3. The ampoule holderaccording to claim 2, wherein the engaging member is on a resilient armwhich extends in one of longitudinal or circumferential directions. 4.The ampoule holder according to claim 3, wherein an injection needleunit can be attached to the fastening member, whereby the needle unitengages the engaging member and the seal.
 5. The ampoule holderaccording to claim 4, wherein the engaging member comprises a latchingelement which at least hinders releasing the needle unit from thefastening member.
 6. The ampoule holder according to claim 1, whereinthe fastening member is attachable to the ampoule receptacle by one of aplugging movement, a rotational movement, or a combination of the twomovements.
 7. The ampoule holder according to claim 1, wherein thefastening member is connected or connectable to the ampoule receptaclevia at least one of a thread, a longitudinal guide, or a bayonet lock.8. An ampoule holder for an ampoule, the ampoule having a central,longitudinal axis and comprising a seal with septum and a radialprojection, the ampoule holder comprising: an ampoule receptacleconfigured to receive the ampoule within an interior via a distal end ofthe ampoule receptacle, said distal end comprising an inner diameterthat is smaller than an outer diameter of the radial projection of theseal such that the radial projection cannot be received within theampoule receptacle interior; and a fastening member connectable to theampoule receptacle with the ampoule receptacle and the fastening memberhaving in common the central, longitudinal axis, wherein one of thefastening member and the ampoule receptacle comprises a latching meansand the other of the fastening member and the ampoule receptaclecomprises a latching counter means, wherein the latching means and thelatching counter means are in engagement or can be engaged when thefastening member is fastened such that the ampoule receptacle and thefastening member provide permanent enclosure of the radial projection ofthe seal seated in a plane perpendicular to the central, longitudinalaxis at a distal end of the ampoule receptacle, with said seal extendinginto the fastening member, and wherein when in engagement, relativemovement between the latching means and the latching counter means ispossible in only one axial, fastening direction to eliminate or reducean axial clearance of the seal between the fastening member and thedistal end of the ampoule receptacle such that the distal end of theampoule receptacle abuts a proximal end of the radial projection of theampoule, and the fastening means and the ampoule receptacle cannot bedisconnected and is permanent under the application of forces to causerelative rotational motion about the common central, longitudinal axisbetween the ampoule receptacle and the fastening member or linear motionin a direction opposite the fastening direction.
 9. The ampoule holderaccording to claim 8, wherein the fastening member can only be moved ina fastening direction when the latching means and the latching countermeans are engaged.
 10. The ampoule holder according to claim 9, whereinthe latching means comprises at least one latching tooth, and thelatching counter means comprises a number of latching teeth shaped suchthat the fastening member can be moved in one direction and cannot bemoved in the other direction.
 11. The ampoule holder according to claim10, wherein the latching teeth are serrated.
 12. The ampoule holderaccording to claim 10, wherein the latching teeth are arrangedconsecutively circumferentially or longitudinally.
 13. The ampouleholder according to claim 12, wherein at least one of the latching meansand the latching counter means is resiliently urged.
 14. The ampouleholder according to claim 13, wherein the ampoule receptacle comprises agroove having two groove flanks, wherein one or both of the grooveflanks form the latching counter means, and wherein the latching meansis resiliently urged against at least one of the groove flanks.
 15. Theampoule holder according to claim 1, wherein at least one of the ampoulereceptacle and the fastening member comprises at least one projectiondirected to press against the seal.
 16. The ampoule holder according toclaim 1, wherein the ampoule is a two-chamber ampoule and the ampoulereceptacle comprises a cavity for forming a bypass for the two-chamberampoule.
 17. An ampoule holder comprising an ampoule receptacle and aneedle unit fastening member connected to the ampoule receptacle withthe ampoule receptacle and the fastening member having a common central,longitudinal axis and an ampoule comprising a cylindrical casing with anouter diameter and a seal with a radial projection extending radiallybeyond the outer diameter, wherein the ampoule comprises at least one ofthe following: two chambers; the seal can be penetrated by a piercingobject that is part of a needle unit; or the seal comprises a septumenclosed at least in the region of the radial extension by an annulardeformable part, wherein the ampoule receptacle is configured to receivethe cylindrical casing within an interior via a distal end of theampoule receptacle, said distal end comprising an inner diameter that issmaller than an outer diameter of the radial projection of the seal suchthat the radial projection cannot be received within the ampoulereceptacle interior, wherein the ampoule receptacle and the fasteningmember provide permanent enclosure of the radial projection of the sealseated in a plane perpendicular to the central, longitudinal axis at adistal end of the ampoule receptacle, with the seal extending into thefastening member and the fastening member comprises a latch which can beconnected to the ampoule receptacle by a counter latch, and wherein whenthe latch and the counter latch are engaged, relative movement betweenthe latch and the counter latch is possible in only an axial, fasteningdirection to eliminate or reduce the axial clearance of the seal betweenthe fastening member such that the distal end of the ampoule receptacleabuts a proximal end of the radial projection of the ampoule, and theampoule receptacle and the fastening member cannot be disconnected fromthe ampoule receptacle with the application of forces to cause relativerotational motion about the common central, longitudinal axis betweenthe ampoule receptacle and the fastening member or linear motion in adirection opposite the fastening direction.
 18. The ampoule holderaccording to claim 17, wherein one of the latch and the counter latch isformed, such that it is resilient, on an arm which extends in acircumferential direction relative to the common longitudinal axis andcan engage with the other of the latch and the counter latch which isformed on an inner circumference of the fastening member.
 19. Theampoule holder according to claim 18, wherein the other of the latch andthe counter latch, formed on the inner circumference of the fasteningmember, comprises serrated teeth, wherein the teeth are arrangedsuccessively in a line.